OuterHealth

A 4-product AI platform for Australian pharmacy.

Starting with compliance — the highest-pain, highest-trust entry point. 7 AI agents that automate regulatory monitoring, documentation, and audit readiness for 5,700+ pharmacies.

The problem

Australian pharmacies operate under some of the most complex regulatory requirements in healthcare. TGA scheduling, PBS claiming rules, Schedule 8 controlled substance tracking, AHPRA registration, state pharmacy board regulations — all enforced simultaneously with severe penalties for non-compliance.

Most pharmacies manage this manually. Pharmacists spend hours each week on documentation, spreadsheets, and audit preparation instead of patient care. The result: compliance gaps that go undetected until a regulator finds them.

This is a systems problem, not a people problem. And it affects every pharmacy in the country.

5700+pharmacies nationally

every one facing the same regulatory burden with fragmented manual tools

<24hrsaudit-ready target

most pharmacies need weeks to prepare — regulators expect immediate readiness

What we solve

01

Continuous compliance monitoring

AI-powered monitoring of every action, formulation, and dispensing event against TGA, AHPRA, PBS, and QCPP requirements. Automated scans every 4 hours with instant alerts for critical violations.

02

Automated documentation

Every Schedule 8 register, PBS reconciliation, and audit report generated automatically. Always current.

03

Risk detection

Machine learning models detect unusual patterns before they become violations. Anomaly detection across dispensing, inventory, and financial actions.

04

Audit readiness

Inspection-ready file packages maintained and updated nightly. Generate QCPP Element 18 evidence, Essential 8 attestations, and TGA documentation on-demand — in under 60 seconds.

ComplianceAI
Active

ComplianceAI

Autonomous compliance monitoring for Australian pharmacy.

7 AI agents that run continuously in the background — monitoring every action, generating required documentation, filing regulatory reports, and maintaining audit-ready file packages. No new systems to learn. Connects to your existing pharmacy software within hours.

How it works

1

Connect

Direct API integration with CompoundDirect, Fred Dispense, Minfos, and other pharmacy management systems. Read-only access — we never modify your operational data. For systems without APIs, secure CSV upload available.

2

Deploy

7 AI agents configured for your pharmacy’s specific TGA, AHPRA, PBS, and QCPP requirements. Baseline scan completes within 48 hours. Integration typically takes 5–7 business days.

3

Monitor

Agents run automated compliance checks every 4 hours — scanning actions, generating documents, detecting anomalies, flagging violations. Critical issues trigger instant email and SMS alerts.

4

Improve

Machine learning models tune to your pharmacy’s patterns over the first 30–60 days, learning normal baselines and reducing false positives. The longer the system runs, the more accurately it detects issues.

5

Report

Weekly compliance summaries, monthly reports, and on-demand audit packages. QCPP Element 18 evidence and TGA documentation generated in under 60 seconds.

What you need to get started

System Access

• Admin credentials for your pharmacy software

• Windows Active Directory access

• Firewall access for monitoring agent

Documentation

• Staff roster (names, roles, AHPRA numbers)

• Existing compliance documentation

• Recent QCPP audit reports (if available)

Coordination

• IT contact information

• Principal pharmacist availability (1–2 hours)

Typical timeline

Week 1

Assessment & integration planning

Week 2

Agent deployment & baseline scan

Week 3

Dashboard config & alert tuning

Week 4

Training & go-live

Monthly maintenance: ~30 minutes (review alerts, upload certificates, confirm deadlines)

7 specialised agents

Each agent handles a specific compliance domain. Together, they cover the full regulatory surface area of an Australian pharmacy.

Transaction Monitoring

Monitors every dispensing event, inventory movement, and financial action. Automated scans every 4 hours with instant alerts for unauthorized activities or policy violations.

Document Generation

Automatically creates Schedule 8 registers, PBS reconciliations, dispensing logs, and audit reports.

Regulatory Filing

Generates compliant reports ready for submission to TGA, AHPRA, Services Australia, and state pharmacy boards. Tracks deadlines and sends proactive reminders.

Audit Readiness

Maintains inspection-ready file packages updated nightly. Generates QCPP Element 18 evidence, Essential 8 attestations, and TGA audit documentation on-demand.

Policy Compliance

Monitors for violations in real-time: prescription authorisation, controlled substances, PBS rules.

Risk Prediction

Machine learning anomaly detection across all action data. Identifies unusual patterns that may indicate compliance issues, diversion, or fraud before they escalate.

Orchestrator

Coordinates all agents, generates unified compliance dashboard with health score (0–100%), prioritizes alerts, and provides weekly summaries with actionable recommendations.

Agent Activity — Live

Built for healthcare

Our technology is purpose-built for regulated healthcare environments.

AI-powered monitoring

Machine learning models continuously analyze action patterns, detect anomalies, and flag potential compliance violations. Automated scans every 4 hours with instant alerts for critical issues.

Adaptive learning

Models tune to your pharmacy’s specific patterns over the first 30–60 days, learning normal baselines and reducing false positives. The longer the system runs, the more accurately it detects issues specific to your pharmacy.

Healthcare-grade security

All data processing compliant with Australian Privacy Act requirements. No patient data leaves your pharmacy system.

Software integration

ComplianceAI integrates directly with the compounding and pharmacy software that powers Australian pharmacy.

CompoundDirect

Compounding pharmacies

API integration

Live

Fred Dispense

~35%

API integration

Live

Minfos

~30%

API integration

Live

Z Dispense

~15%

API integration

In development

Simple Aquarius + others

~10%

CSV + manual upload

Research
Total addressable coverage90%+ of Australian pharmacies

Don’t see your system? We support CSV export from any pharmacy management platform. Contact us to discuss integration options.

PharmConnect

The infrastructure layer for pharmacy commerce.

ComplianceAI monitors your pharmacy. PharmConnect connects it. We build and operate wholesale marketplaces for pharmacies and develop middleware that integrates with any pharmacy management system — enabling direct connections between pharmacies, wholesalers, and customers.

Same infrastructure. PharmConnect uses the same API connections as ComplianceAI. Once your pharmacy is connected for compliance monitoring, the same integration powers wholesale ordering and customer app features — no additional setup required.

01

Wholesale Marketplace

Purpose-built trading platforms connecting pharmacies directly with pharmaceutical wholesalers. Streamlined ordering, transparent pricing, and automated procurement workflows.

02

Pharmacy Middleware

API middleware that connects to CompoundDirect, Fred Dispense, Minfos, and other pharmacy software. One integration layer that bridges any system to any service — wholesale ordering, customer apps, compliance monitoring.

03

Customer App Integration

Direct-to-customer connections that streamline prescription ordering and management. Patients interact through a modern app experience while the pharmacy operates through their existing software.

What ComplianceAI doesn’t replace

ComplianceAI is a monitoring and documentation platform — not a replacement for professional judgment or existing systems.

×

Your professional judgment

ComplianceAI flags issues and provides recommendations. Final compliance decisions remain with your principal pharmacist.

×

Manual regulatory submissions

We generate compliant reports ready for submission to TGA, AHPRA, and Services Australia. You or your staff submit them.

×

Your existing pharmacy software

ComplianceAI monitors CompoundDirect, Fred Dispense, or Minfos — it doesn’t replace your dispensing system.

×

Legal or regulatory advice

We provide compliance monitoring, not legal interpretation. Complex regulatory questions should be reviewed with your pharmacy lawyer.

×

IT support

ComplianceAI monitors compliance, not IT infrastructure. You’ll still need your IT vendor for hardware and network issues.

What ComplianceAI does

Monitors your systems 24/7 for compliance violations

Generates required documentation automatically

Maintains audit-ready evidence packages

Tracks regulatory deadlines and alerts proactively

Reduces compliance workload from hours to minutes

Get started

Start with a compliance gap assessment

Before deploying ComplianceAI, understand your current compliance status with a comprehensive audit of your pharmacy’s TGA, AHPRA, PBS, and QCPP requirements.

• On-site assessment (half-day visit)

• Review of all systems and compliance documentation

• Detailed findings report (delivered within 7–10 business days)

• Gap analysis with remediation priorities

• Financial exposure estimate (potential penalty risk)

• Implementation roadmap with cost estimates

How it works

1

Assessment

Half-day on-site compliance gap assessment. Report delivered within 7–10 business days.

2

Decision

Review the report and decide if ComplianceAI is right for your pharmacy. No obligation to proceed.

3

Deploy

Integration typically completes within 5–7 business days, with agents operational within 48 hours of connection.

4-product platform

ComplianceAI is product one. Each subsequent product builds on the data connections and trust established by the previous.

Now

ComplianceAI

Autonomous compliance monitoring, documentation, and audit readiness. 7 AI agents running continuously across every compliance domain.

Active

PharmConnect

Wholesale marketplace, pharmacy middleware, and customer app integration. The infrastructure layer connecting pharmacies to wholesalers and customers.

Building

PharmTrade

Peer-to-peer medication exchange. An AI-powered marketplace connecting pharmacies with shortages to pharmacies with surplus.

Future

PharmInsight

Predictive intelligence from aggregated, anonymised pharmacy data for manufacturers, wholesalers, and government agencies.

Market opportunity

Australian independent pharmacies face complex, overlapping regulatory requirements. ComplianceAI is built specifically for this environment — Australian regulations, Australian pharmacy systems, Australian compliance standards.

5,700+independent pharmacies

in Australia

90%+software coverage

of Australian pharmacies supported

Results

Target performance metrics based on pilot design and regulatory requirements.

65%compliance score

typical baseline — most pharmacies don't know how exposed they are

<24hrsaudit-ready

from weeks of preparation to always ready

90%+retention target

Compliance is mission-critical \u2014 pharmacies don\u2019t switch once deployed

Before

  • Manual action review and spreadsheet tracking
  • Weeks of preparation before regulatory audits
  • Paper-based Schedule 8 registers
  • Reactive compliance — issues found by regulators
  • 5–8 hours per week on compliance administration

After

  • AI agents monitoring actions continuously
  • Always audit-ready — packages generated in <60 seconds
  • Digital registers with cryptographic audit trails
  • Proactive compliance — violations caught before inspections
  • 30 minutes per month on compliance review (96% time reduction)
Now available

Start with a conversation.

Book a free introduction call. We’ll walk you through how ComplianceAI works and what it can do for your pharmacy.